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Project Raising Exposure Awareness for Caregiver Help-Seeking (Project REACH)

5 de noviembre de 2026 actualizado por: Hannah Frank, Brown University

A Direct-to-consumer Dissemination Campaign About Exposure to Increase Treatment Access

The goal of this pilot randomized study is to learn whether a dissemination campaign co-designed with a community advisory board helps caregivers of children with anxiety and related disorders seek exposure therapy, compared with standard information. Participants are caregivers of children ages 4 to 18 with current anxiety, OCD, or traumatic stress symptoms.

The main questions it aims to answer are:

Does the dissemination campaign improve caregivers' knowledge of exposure therapy, attitudes toward it, perceived norms about seeking it, and confidence that they can find an exposure therapist, compared with dissemination-as-usual?

Does the dissemination campaign increase caregivers' intentions to seek exposure therapy for their child, compared with dissemination-as-usual?

Researchers will compare the dissemination campaign to dissemination-as-usual, which is links to professional organization websites and advice to contact their insurance company or search an online therapist directory.

Participants will:

  • Complete an online survey about their help-seeking intentions, knowledge, attitudes, norms, and confidence
  • Be randomly assigned to review either the dissemination campaign or dissemination-as-usual materials for at least 10 minutes
  • Complete the same survey again right after reviewing the materials
  • Possibly be invited to a 15-minute phone interview 2 months later about whether they sought treatment for their child and what barriers they faced

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Adult (age 18 or older) parent or other family caregiver Has a child aged 4 to 18 years with current symptoms of anxiety, obsessive-compulsive disorder (OCD), and/or traumatic stress, by caregiver report Able to read and understand English Able to provide informed consent

Exclusion Criteria:

Survey responses flagged as likely invalid or inaccurate during data screening, including uniform responding or duplicate or suspicious IP addresses Previous participation in this study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Tailored Dissemination Campaign

Caregivers are randomized to review the community advisory board-designed dissemination campaign, including flyers, infographics, testimonial videos, and explainer video.

A direct-to-consumer dissemination campaign about exposure therapy for youth anxiety and related disorders, co-designed with a community advisory board of family caregivers and providers and refined through caregiver focus groups. It covers the same core content as standard information about finding mental health care, but uses terminology and explanations developed with the advisory board. It also includes a skills-focused "how-to" guide for finding and accessing an exposure therapist. The campaign targets help-seeking mechanisms from the Theory of Planned Behavior: knowledge, attitudes, perceived norms, and self-efficacy. Participants review the materials online for at least 10 minutes.

Comparador activo: Dissemination-as-usual

Caregivers are randomized to review standard information about finding mental health services for their child (e.g., information found via google and foundation websites)

Standard information about seeking mental health care for a child: links to professional organization websites and summary of information generated from Google searches. Participants review the materials online for at least 10 minutes.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Caregiver Self-Efficacy for Seeking Exposure Therapy
Periodo de tiempo: Baseline (pre-review) and immediately post-review (same study session)

Self-efficacy for finding an exposure therapist for one's child, measured with two caregiver-report items rated on a 7-point agreement scale (e.g., "If I really wanted to, I could find an exposure specialist for my child"). The items are averaged into a score from 1 to 7, and higher scores indicate greater self-efficacy. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Caregiver Attitudes Toward Exposure Therapy
Periodo de tiempo: Baseline (pre-review) and immediately post-review (same study session)

Attitudes toward exposure therapy, measured with four standard semantic differential scales. The total score is the average of z-standardized items, and higher scores indicate more favorable attitudes. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Perceived Norms for Seeking Exposure Therapy
Periodo de tiempo: Baseline (pre-review) and immediately post-review (same study session)

Perceived norms about seeking exposure therapy, measured with two items rated on a 7-point agreement scale. One asks whether "other caregivers like me" would seek exposure therapy, and the other asks whether people important to the caregiver would approve. The items are averaged into a score from 1 to 7, and higher scores indicate more favorable perceived norms. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Caregiver Intentions to Seek Exposure Therapy
Periodo de tiempo: Baseline (pre-review) and immediately post-review (same study session)

Strength of caregivers' intentions to seek exposure therapy for their child, measured with two items rated on a 7-point scale: how willing and how likely the caregiver is to seek exposure therapy. The items are averaged into a score from 1 to 7, and higher scores indicate stronger intentions. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Caregiver Knowledge of Exposure Therapy
Periodo de tiempo: Baseline (pre-review) and immediately post-review (same study session)

Caregiver awareness of and prior experience with exposure therapy, measured with a previously developed two-item measure. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Acceptability of Dissemination Strategies
Periodo de tiempo: Immediately post-review (same study session)

Caregiver ratings of the acceptability of each dissemination strategy developed with the community advisory board.

Immediately post-review (same study session)
Caregiver-Reported Connection to Mental Health Services
Periodo de tiempo: 2 months post-review

Number of caregivers in a purposive subsample (n=32; 16 per arm, selected for high or low baseline intentions) who report successfully connecting their child with mental health services, and the type of treatment sought (including exposure therapy). This is assessed in a 15-minute structured phone interview. Reported barriers to accessing care and the influence of study materials on help-seeking will be analyzed qualitatively with rapid qualitative analysis, using codes from the Theory of Planned Behavior.

2 months post-review

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de enero de 2027

Finalización primaria (Estimado)

15 de junio de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

5 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Publicado por primera vez (Actual)

10 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY00000708
  • U54GM115677 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data from the quantitative surveys will be shared, including baseline and post-review measures of help-seeking intentions, knowledge, attitudes, perceived norms, self-efficacy, and acceptability, along with de-identified demographic and child symptom data. Qualitative interview transcripts will not be shared, to protect participant confidentiality.

Marco de tiempo para compartir IPD

Data will be available beginning 6 months after publication of the primary results and for at least 3 years after that.

Criterios de acceso compartido de IPD

Data will be available to qualified researchers who submit a methodologically sound proposal to the study PI and sign a data use agreement

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .